Troubleshooting Microbial Excursions Best Practices - FDA and USP Regulatory Expectations & Guidance for Industry
Live, Interactive Training Webinar
Available Live On-Demand
Instructor: Barry A.Friedman Ph.D. Biography>>>
Available Live On-Demand
Microbial Excursions are an often observed issue that occur with both non-sterile and sterile products in controlled and classified environments as well as within the microbiological laboratory. Various regulators will cite firms for these Excursions under a variety of different sections of the Code of Federal Register (CFR) to include 21 CFR 211.113(a) and (b), 211.84(d)(6), 211.165(b), and 211.192. Excursions are also cited as per United States Pharmacopeia to include USP<51>, <61>, <62>, <71>, <1072>, <1111>, and <1116>. Also, various Guidance for Industry are also included and often used within citations. One of the most notable is the September 2004 Guidance for Industry on Aseptic Processing.
Some of the most frequent excursions include those within the laboratory, the classified environment, non-conformances of personnel, and cleaning and disinfection practices. This live training webinar will review various Investigations – using various FDA Warning Letters to explore issues with bacteria and fungi. A chronology will also be included that reviews “Troubleshooting Microbial Excursions”.
The Objective of this live training webinar will be to explore the “Best Practices for Troubleshooting Microbial Excursions” and examine solutions to common microbiological problems. Please plan to bring a team to this Webinar to explore how these issues may assist you in your facilities.
-An Overview of “Best Practices for Troubleshooting Microbial Excursions”. -Various Code of Federal Register regulations, USP and FDA Guidance for Industry documents used by Regulators in Citations. -Learn about the Legal Framework behind these Documents. -Learn about Laboratory, the Classified Environment, Non-conformances of Personnel, and Cleaning and Disinfection Practices. -Participate in an Overview of a “Troubleshooting” Exercise. -Experience what Companies have encountered with Warning Letters.
Webinar outline and time breakdown:
|10:15 AM||Log In Period|
|10:40 AM||Overview of “Best Practices”,|
|Overview of CFRs, USP and Guidance documents that control “Best Practices”,|
|Learn about the Legal Framework behind the above documents,|
|11:40 AM||Learn about Laboratory, the Classified Environment,|
|How to Use Parametric Methods,|
|Non-conformances of Personnel, and Cleaning and Disinfection Practices,|
|Participate in an Overview of a “Troubleshooting” Exercise,|
|Experience what Companies have encountered with Warning Letters,|
|12:30 PM||Live Questions & Discussion|
*Please note all times are Eastern Time (New York Time)
This live training webinar includes the following for each registered attendee:
- A copy of the presentation slides
- A certificate of training for attendee records
Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:
- Quality Assurance personnel
- Quality Control personnel
- Research & Development
- Regulatory Affairs Professionals
- Auditing Professionals
- Microbiology Professionals
- Those that use contract manufacturing and contract testing facilities
Instructor: Barry A. Friedman Ph.D.
Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing arena. Dr. Friedman is a frequent seminar speaker in the GMP areas of internal auditing, aseptic processing of sterile drug products, USP microbiology, validations and the requirements for the manufacture of Phase 1, 2 and 3 clinical trial materials. He has recently given presentations for the FDA, PDA, PTi. He is a member of AAMI, ASM, PDA and RAPS. He served as a Captain in the Medical Service Corps, U.S. Army and is the past President of the Capital Area Chapter, PDA... Full Bio>>>
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